Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors

NCT ID: NCT01564498

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-12-31

Brief Summary

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The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds including anthocyanins will have higher antioxidant and other biological activities, than more lightly coloured versions of these foods. Diets of human subjects will be modified to allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be randomized to consume either orange or purple carrots, or white or purple potatoes. They will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as well as anthropometry and blood biochemistry for changes in risk factors associated with cardiovascular disease.

Detailed Description

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Conditions

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Hypertension Hypercholesterolemia Type II Diabetes Obesity Inflammation

Keywords

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anthocyanins antioxidant polyphenols bioavailability cholesterol insulin sensitivity glucose tolerance atherosclerosis metabolic syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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White potato

Participants will consume 300-500 g of cooked white potatoes per day

Group Type PLACEBO_COMPARATOR

vegetable

Intervention Type OTHER

200-300 g raw carrots or 300-500 g cooked potatoes

Purple Potato

Participants will consume 300-500 g of cooked purple potato per day

Group Type EXPERIMENTAL

vegetable

Intervention Type OTHER

200-300 g raw carrots or 300-500 g cooked potatoes

Orange carrots

Participants will consume 200-300 g typical varieties of orange carrots during the intervention

Group Type PLACEBO_COMPARATOR

vegetable

Intervention Type OTHER

200-300 g raw carrots or 300-500 g cooked potatoes

Purple Carrots

Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm

Group Type EXPERIMENTAL

vegetable

Intervention Type OTHER

200-300 g raw carrots or 300-500 g cooked potatoes

Interventions

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vegetable

200-300 g raw carrots or 300-500 g cooked potatoes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult men and women 18-65 years of age
* must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:

* borderline high or hypertension or undergoing treatment for such
* abnormal fasting blood glucose or undergoing treatment for such
* overweight or obese
* borderline high or high LDL-cholesterol or undergoing treatment for such
* borderline low or low HDL-cholesterol
* borderline high or high triglycerides or undergoing treatment for such

Exclusion Criteria

* smokers, pregnant or nursing women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Ministry of Agriculture, Food and Rural Affairs

OTHER_GOV

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Kelly Anne Meckling, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kelly A Meckling, PhD

Role: CONTACT

Phone: 5198244120

Email: [email protected]

Saqib Mannan, BSc

Role: CONTACT

Phone: 5198244120

Email: [email protected]

Facility Contacts

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Amanda J Wright, PhD

Role: primary

Amy Tucker, PhD

Role: backup

Other Identifiers

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2012MeckPurpleVeg

Identifier Type: -

Identifier Source: org_study_id